2. Clarity of State Guidance on Infection-Related Health Services in Substance Abuse Treatment Programs L.S. Brown, MD, MPH; S. Kritz, MD; J. Rotrosen, MD; R.J. Goldsmith, MD; E. Bini, MD, MPH; J. Robinson, MEd, D. Alderson, MS and the NIDA Clinical Trials Network Infections Study (CTN-0012) Team Addiction Research & Treatment Corp, Brooklyn, NY; NYU School of Medicine and VA Hospital, NY, NY; University of Cincinnati Medical Center, Cincinnati, OH; Nathan Kline Institute, Orangeburg, NY; and NYS Psychiatric Institute, NY, NY

3. ABSTRACT ABSTRACT Background: The Infections and Substance Abuse Study (NIDA CTN-0012) examined associations between services provided for HIV/AIDS, hepatitis C viral infection (HCV), and sexually transmitted infection (STI) at substance abuse treatment programs in the National Drug Abuse Treatment Clinical Trials Network (NIDA CTN), and the states within which they are located. This report specifically looks at the relationships between clarity of state policy, regulations and guidelines as viewed by clinicians, and the availability of eight infection-related services for all three disease groups. Methods: Data for this report was derived from three surveys: one for state health and substance abuse department administrators, and one each for substance abuse treatment program clinicians and administrators. The surveys included questions dealing with eight infection-related services: provider education, patient education, risk assessment, counseling, medical history and physical exam, biological testing, treatment and monitoring. Results: Administrators of state substance abuse and/or health departments from 48 states and the District of Columbia participated. Surveys were also obtained from 1723 clinicians (78%) within the NIDA CTN: 251 medical experts (15%), 522 non-medical experts (30%), 115 medical non-experts (7%) and 831 non-medical non-experts (48%). Completed surveys were obtained from 269 of 319 administrators (84%). With few exceptions, clinician assessment of clarity of state policies, regulations and guidelines for the eight targeted services was generally about 50% or less for all three infection groups. Six of eight services were provided by a similar percentage of programs, regardless of state mandates. Two services (treatment and monitoring) were provided by a substantially higher percentage of sites where there were state policies, regulations or guidelines. Discussion: This information suggests that state policies, regulations or guidelines are often not clearly understood by clinicians, and even where they exist, they are not sufficient to assure "best practices" in treating these epidemic infections.

4. ACKNOWLEDGEMENTS Research Supported by the National Institute on Drug Abuse (NIDA) as part of a Cooperative Agreement (1U10DA013046) with the NIDA CTN; and other Protocol Team members consisting of: Research Supported by the National Institute on Drug Abuse (NIDA) as part of a Cooperative Agreement (1U10DA013046) with the NIDA CTN; and other Protocol Team members consisting of: –Randy Seewald, MD; Cheryl Smith, MD; Frank McCorry, PhD; Dennis McCarty, PhD; Donald Calsyn, PhD; Leonard Handelsman, MD; Steve Kipnis, MD –Patrick McAuliffe, MBA, LADC; Al Hassen, MSW; Karen Reese, CAC-AD; Sherryl Baker, PhD –Shirley Irons; Kathlene Tracy, PhD

5. Drug Abuse Treatment Clinical Trials Network Philadelphia Portland Los Angeles Charleston Miami Cincinnati Denver CTN Sites Seattle Raleigh/ Durham Long Island Boston San Francisco (CA/AZ Node) New York City Detroit Albuquerque Baltimore/Richmond New Haven 17 Nodes with 116 Community Treatment Agencies Reaching into 26 States!

6. STUDY SITES STUDY SITES New York Node: New York University, New York, NY New York Node: New York University, New York, NY South Carolina Node: Medical University of South Carolina, Charleston, SC South Carolina Node: Medical University of South Carolina, Charleston, SC Florida Node: University of Miami, Coral Gables, FL Florida Node: University of Miami, Coral Gables, FL Great Lakes Node: Wayne State University, Detroit, MI Great Lakes Node: Wayne State University, Detroit, MI Ohio Valley Node: University of Cincinnati, Cincinnati, OH Ohio Valley Node: University of Cincinnati, Cincinnati, OH Rocky Mountain Node: University of CO Health Sciences Center, Denver, CO Rocky Mountain Node: University of CO Health Sciences Center, Denver, CO New England Node: Yale University, New Haven, CT New England Node: Yale University, New Haven, CT Delaware Valley Node: University of Pennsylvania, Philadelphia, PA Delaware Valley Node: University of Pennsylvania, Philadelphia, PA Mid-Atlantic Node: Johns Hopkins Univ., Baltimore, MD; Medical College Mid-Atlantic Node: Johns Hopkins Univ., Baltimore, MD; Medical College of Virginia, Richmond of Virginia, Richmond Pacific Region Node: University of California at Los Angeles, CA Pacific Region Node: University of California at Los Angeles, CA Oregon Node: Oregon Health Sciences University, Portland, OR Oregon Node: Oregon Health Sciences University, Portland, OR Washington Node: University of Washington, Seattle, WA Washington Node: University of Washington, Seattle, WA Long Island Node: NY State Psychiatric Institute, New York, NY Long Island Node: NY State Psychiatric Institute, New York, NY North Carolina Node: Duke University, Raleigh/Durham, NC North Carolina Node: Duke University, Raleigh/Durham, NC Southwest Node: University of New Mexico, Albuquerque, NM Southwest Node: University of New Mexico, Albuquerque, NM Northern New England Node: McLean Hospital, Belmont, MA Northern New England Node: McLean Hospital, Belmont, MA California-Arizona Node: University of California at San Francisco, CA California-Arizona Node: University of California at San Francisco, CA

7. STUDY RATIONALE STUDY RATIONALE HIV/HCV/STI: major causes of excess morbidity and mortality in the US HIV/HCV/STI: major causes of excess morbidity and mortality in the US Substance abuse: a major vehicle for the transmission of infection Substance abuse: a major vehicle for the transmission of infection Scope of, and challenges to identifying, counseling, and treating persons with these infections in substance abuse treatment will assist in developing effective interventions Scope of, and challenges to identifying, counseling, and treating persons with these infections in substance abuse treatment will assist in developing effective interventions

8. IMPORTANT ABREVIATIONS IMPORTANT ABREVIATIONS HIV = Human Immunodeficiency Virus HIV = Human Immunodeficiency Virus AIDS = Acquired Immunodeficiency Syndrome AIDS = Acquired Immunodeficiency Syndrome HCV = Hepatitis C Virus HCV = Hepatitis C Virus STI = Sexually Transmitted Infections STI = Sexually Transmitted Infections CTP = Community Treatment Program CTP = Community Treatment Program CTN = Clinical Trials Network CTN = Clinical Trials Network SOP = Standard Operating Procedures SOP = Standard Operating Procedures IRB = Institutional (Human Subject) Review Board IRB = Institutional (Human Subject) Review Board

9. IMPORTANT DEFINITIONS IMPORTANT DEFINITIONS Treatment Program vs. NIDA CTN CTP Treatment Program vs. NIDA CTN CTP Services Assessed Services Assessed –Provider Education –Patient Education –Patient Risk Assessment –Patient Counseling –Patient Medical History & Physical Exam –Patient Biological Testing –Patient Treatment –Patient Monitoring Medical vs. Non-Medical Clinical Staff Medical vs. Non-Medical Clinical Staff ‘Expert’ vs. ‘Non-expert’ Clinical Staff ‘Expert’ vs. ‘Non-expert’ Clinical Staff

10. PRIMARY OBJECTIVES TO DESCRIBE: TO DESCRIBE: –Range of Infection-Related Services Available –Clinician Characteristics (training, knowledge, behavior) –Opinions –Perceived Barriers to Providing Infection-Related Services TO EXAMINE ASSOCIATIONS BETWEEN: TO EXAMINE ASSOCIATIONS BETWEEN: –CTPs ’ Availability of Selected Infection Services –Other Constructs Listed Above

11. DESIGN AND POPULATION STUDY DESIGN STUDY DESIGN –Cross-sectional Survey –Descriptive & Exploratory STUDY POPULATION STUDY POPULATION –Administrators of State Health Departments and State Substance Abuse Agencies –Treatment Program Clinicians –Treatment Program Administrators

12. ETHICAL, REGULATORY & ADMINISTRATIVE CONSIDERATIONS Expedited IRB Approval Expedited IRB Approval Waiver of Informed Consent Waiver of Informed Consent Training for Node Protocol Managers Training for Node Protocol Managers

13. STUDY PROCEDURES STUDY PROCEDURES Node Protocol Managers Node Protocol Managers Information Sheet In Lieu of Informed Consent Information Sheet In Lieu of Informed Consent Survey Administration Survey Administration – Paper or Electronic – Central data acquisition

14. State Surveys Data Center mails survey material to State Administrators Project Manager enters State Administrator contact information into the Data Center system State Administrator completes the survey online or mails to Data Center Project Manager contacts State Administrators that have not completed survey within 30 days After four weekly attempts to contact State Administrators, the Project Manager flags them as non-responders Project Manager contacts State Administrators to resolve data queries Data Center reviews data and communicates any issues to Project Manager

15. Clinician Surveys Statistician selects Clinicians from Treatment Programs based on contact information provided by Administrators Clinician surveys mailed Gathering sessions held for Clinicians to complete surveys Clinician completes survey online or mails to Data Center Completed surveys mailed to Data Center Data Center contacts non- responders after 30 days; flagged as non-responders after four weekly failed attempts If non-responder is a randomly selected Clinician, the next eligible Clinician on the selection list is sent a survey Data Center monitors the data entry of Clinicians Data Center contacts Clinicians to resolve any data queries Randomization

16. Administrator Surveys Contact CTP Directors for Treatment Program and Administrator contact information Survey materials mailed to Administrators Ensure IRB approval Administrator completes survey online or mails to Data Center; Administrator enters contact information for Clinicians Node Protocol Manager contacts Administrators that have not responded within two weeks Data Center contacts Administrators that have not completed the survey or Clinician contact information within 30 days Data Center contacts Administrators to resolve any data queries After four weekly attempts, Administrators flagged as non-responders by the Data Center Node Protocol Managers contact non- responder Administrators weekly For Administrators that refuse to participate or still have not responded after two additional weeks, the Node Protocol Manager alerts the Node Principal Investigator

17. MEASUREMENTS & ANALYTICAL METHODS SAMPLING METHODOLOGY: At Each Treatment Program … SAMPLING METHODOLOGY: At Each Treatment Program … – All ‘Expert’ Clinicians Designated by the CTP – 10 randomly sampled ‘Non-Expert’ Clinicians, in a ratio of Medical:Non-Medical reflecting that of in a ratio of Medical:Non-Medical reflecting that of the CTP’s clinical staff the CTP’s clinical staff – All Treatment Program Administrators ANALYTIC METHODOLOGIES ANALYTIC METHODOLOGIES – ‘Experts’ will be analyzed separately – Clinicians may decline; next randomly selected person will be asked to participate selected person will be asked to participate

18. STATISTICAL ELEMENTS Sample Size and Precision of the Estimated Mean Sample Size and Precision of the Estimated Mean Analytic Plan Analytic Plan –Descriptive stats for survey variables –Principal Component or Cluster or Factor Analysis to group and reduce the number of variables –Structural Equation Models to test for associations

19. RESULTS Surveys obtained from at least one substance abuse or health department administrator from 48 states and the District of Columbia (96%). Surveys obtained from at least one substance abuse or health department administrator from 48 states and the District of Columbia (96%). Surveys Obtained from 1719 Clinicians of 2207 Targeted (78%) Surveys Obtained from 1719 Clinicians of 2207 Targeted (78%) –831 Non-Medical Non-Experts (48%) –115 Medical Non-Experts (7%) –522 Non-Medical Experts (30%) –251 Medical Experts (15%) Surveys Obtained from 269 Administrators of 319 Targeted (84%) Surveys Obtained from 269 Administrators of 319 Targeted (84%)

20. CLARITY OF HIV GUIDELINES: % OF CLINICIANS SCORING GUIDELINES AS CLEAR NON - EXPERT EXP EXPERT SERVICENon-MedMedicalNon-MedMedicalOVERALL Provider Education 50%55%56%49%52% Patient Education 57%60%66%54%60% Risk Assessment 57%54%65%59%60% History & Physical Exam 56%66%53%76%58% Testing35%47%42%59%41% Counseling49%52%54%58%52% Treatment43%55%46%55%47% Monitoring39%42%38%51%41%

21. CLARITY OF HCV GUIDELINES: % OF CLINICIANS SCORING GUIDELINES AS CLEAR NON - EXPERT EXP EXPERT SERVICENon-MedMedicalNon-MedMedicalOVERALL Provider Education 42%53%43%45%43% Patient Education 48%54%51%48%49% Risk Assessment 48%50%54%54%51% History & Physical Exam 53%64%50%74%56% Testing32%44%37%54%37% Counseling41%47%45%51%44% Treatment39%52%40%48%41% Monitoring35%42%32%43%36%

22. CLARITY OF STI GUIDELINES: % OF CLINICIANS SCORING GUIDELINES AS CLEAR NON - EXPERT EXP EXPERT SERVICENon-MedMedicalNon-MedMedicalOVERALL Provider Education 40%50%41%40%41% Patient Education 47%51%50%41%47% Risk Assessment 46%48%51%46%48% History & Physical Exam 49%64%49%73%53% Testing28%42%35%50%35% Counseling39%45%44%44%41% Treatment37%53%40%51%41% Monitoring32%42%31%43%34%

23. HIV/AIDS, HCV & STI-RELATED SERVICES IN SUBSTANCE ABUSE TREATMENT PROGRAMS: NIDA CTN ADMINISTRATOR RESPONSES (N=269) HIV/AIDSHCVSTIs SERVICE n (%) Provider Education 186 (69) 171 (63) 155 (57) Patient Education 226 (84) 200 (74) 205 (76) Risk Assessment 224 (89) 194 (77) 195 (77) History & Physical Examination 150 (56) 135 (50) 133 (49) Testing 131 (49) 93 (34) 109 (40) Counseling 178 (66) 159 (59) 163 (60) Treatment 103 (38) 78 (29) 92 (34) Monitoring 117 (43) 95 (35) 105 (39)

24. SUMMARY Clarity of guidelines for the 8 targeted services is generally about 50% or less for all three infection groups, with the following exceptions: Clarity of guidelines for the 8 targeted services is generally about 50% or less for all three infection groups, with the following exceptions: –History & Physical Exam (medical experts and non-experts) for all three infection groups –Patient Education and Risk Assessment (non- medical experts) for HIV

25. SUMMARY SUMMARY There is… There is… –substantial variation in the % of programs offering the various services for a particular infection group –consistency in the % of programs offering a particular service for all three infection groups

26. SUMMARY SUMMARY Significant opportunities exist to explore other associations between the HIV/AIDS, HCV & STI-related services offered and… Significant opportunities exist to explore other associations between the HIV/AIDS, HCV & STI-related services offered and… –Clinician Characteristics (training, knowledge, behavior) –Opinions –Perceived Barriers to Providing Infection- Related Services